DE202012013243U1 - Drug delivery device and cartridge holder for a drug delivery device - Google Patents

Abstract

A drug delivery device (1) comprising - a cartridge holder (2) comprising at least one guide track (12), - a body (3) comprising at least one interaction element (13) designed and arranged for mechanical cooperation with the at least one guide track (12) Guideway (12) comprises a first portion (12A) and a second portion (12B), wherein the path defined by the first portion (12A) forms an angle with the longitudinal axis (14) of the device (1), wherein the angle subtended by the path defined by the first section (12A) with the longitudinal axis (14) is less than the angle enclosed by the path defined by the second section (12B) with the longitudinal axis (14) in that, for connecting the cartridge holder (2) to the body (3), the interaction element (13) is designed to mechanically cooperate with the first portion (12A) so that the cartu 2) is axially moved and rotated with respect to the body (3), and the interaction element (13) is designed to mechanically cooperate with the second section (12B) so that the cartridge holder (2) moves relative to the body (3 ), whereby an axial movement of the cartridge holder (2) relative to the body (3) is prevented, characterized in that the guide track (12) is arranged at the proximal end portion of the cartridge holder (2), the proximal end portion being at least one Recess (16), wherein the guide track (12) is arranged so that the distal end of the recess (16) merges into the proximal end of the first portion (12A) of the guide track (12).

Description

The present disclosure relates to a drug delivery device. The disclosure further relates to a cartridge holder for a drug delivery device.

In a drug delivery device, a plug within a cartridge containing a plurality of doses of a drug is often displaced by a piston rod. As a result, a dose of the drug is expelled from the cartridge. Often the cartridge is stabilized by a cartridge holder.

For example, a drug delivery device is described in the document EP 1 923 083 A1 described.

An object of the present disclosure is to provide an improved drug delivery device, such as a device with increased user comfort. Furthermore, a cartridge holder is provided which facilitates the handling of an improved drug delivery device.

This object can be achieved by the subject matter of the independent claims. Advantageous embodiments and refinements are the subject of the dependent claims.

One aspect relates to a drug delivery device. The device may include a cartridge holder. The cartridge holder may comprise at least one, preferably two or more, guideways. The device may comprise a body. The body may comprise at least one, preferably two or more, interaction elements. The interaction element may be configured and arranged to mechanically cooperate with the at least one guideway. The guideway advantageously comprises a first and a second section. The first portion may extend obliquely relative to the longitudinal axis of the device. In particular, the path defined by the first section includes an angle with the longitudinal axis of the device. The second portion may be less oblique relative to the longitudinal axis of the device than the first portion. In particular, the angle enclosed by the path defined by the first section with the longitudinal axis of the device may be less than the angle enclosed by the path defined by the second section with the longitudinal axis of the device. The second section may extend transversely with respect to the longitudinal axis of the device. For preferably releasably connecting the cartridge holder to the body, the interaction element may be configured to mechanically cooperate with the first portion such that the cartridge holder is axially moved and rotated relative to the body. Further, the interaction member for preferably releasably connecting the cartridge holder to the body may be configured to mechanically cooperate with the second portion to rotate the cartridge holder relative to the body. Thereby, axial movement of the cartridge holder relative to the body can be prevented.

When the interaction element mechanically interacts with the guideway, the cartridge holder performs, inter alia, a rotary motion. In particular, the rotational movement is already being performed as the cartridge holder is moved toward the body to connect the cartridge holder to the body, i. H. when the interaction element mechanically cooperates with the first section. The rotational movement is a user-familiar movement, as is known from ordinary screw thread connections. Thus, the user can feel familiar with the movement to connect. In particular, this movement to connect the cartridge holder can be helpful in that the user can easily trust in the secure connection of the cartridge holder to the body. In this way, the handling of a device is facilitated, which offers increased user comfort.

The mechanical interaction of the interaction element and the first section may be followed by mechanical interaction of the interaction element and the second section to connect the cartridge holder to the body. Axial movement of the cartridge holder relative to the body can be prevented when the interaction element mechanically cooperates with the second portion. This may help to indicate to the user that the cartridge holder is near an end position relative to the body, particularly a position where the cartridge holder is firmly connected to the body. In this way, the user comfort can be further increased.

The interaction element and the first and second sections may have dimensions at which the interaction element abuts the walls of the respective section at any time during the connection operation. In particular, the interaction element can fit exactly in the corresponding section. In this way, a smooth movement of the cartridge holder for connection can be facilitated, which helps to further increase user comfort.

In one embodiment, during mechanical interaction of the interaction member with the first and second portions, the cartridge holder is rotated only in a first direction relative to the body.

Accordingly, the cartridge holder can always be rotated in the same direction during the connecting operation. No reverse rotation, and in particular no change in the direction of rotation, is required to connect the cartridge holder to the body, which could mistakenly make the user believe the cartridge holder is not securely attached to or even detached from the body.

In one embodiment, the second portion includes an angular end stop element. The angled end stop member may comprise a side wall of the second portion. The angled end stop member may be configured and arranged to prevent further relative rotation of the cartridge holder and the body in the first direction by mechanical interaction of the angular end stop member with the interaction member.

The angled end stop member may be configured to indicate the end position of the cartridge holder relative to the body. Thus, if the user can not continue to rotate the cartridge holder in the first direction relative to the body, he automatically knows that the cartridge holder has been firmly connected to the body. In this way, the user comfort can be further increased.

In one embodiment, the cartridge holder is rotated less than one revolution relative to the body when the interaction element mechanically cooperates with the first portion. The cartridge holder may be rotated less than one revolution relative to the body when the interaction element mechanically cooperates with the second portion.

The cartridge holder can be rotated by a minimum angle of 5 degrees when the interaction element mechanically interacts with the first portion. The cartridge holder can be rotated by a maximum angle of 120 degrees when the interaction element mechanically interacts with the first portion. For example, the cartridge holder can be rotated through an angle between 10 degrees and 50 degrees. Preferably, the cartridge holder is rotated through an angle of 30 degrees when the interaction element mechanically cooperates with the first portion.

The cartridge holder can be rotated by a minimum angle of 5 degrees when the interaction element mechanically interacts with the second portion. The cartridge holder can be rotated by a maximum angle of 90 degrees when the interaction element mechanically interacts with the second portion. For example, the cartridge holder can be rotated through an angle between 10 and 20 degrees when the interaction element mechanically cooperates with the second portion. Preferably, the cartridge holder is rotated through an angle of 15 degrees when the interaction element mechanically cooperates with the second portion.

Turning the cartridge holder less than one turn during the connection process can further increase user comfort as the user only has to make small and easily maneuverable movements of the cartridge holder to securely connect the cartridge holder to the body.

In one embodiment, the cartridge holder is rotated a greater angle relative to the body when the interaction element mechanically cooperates with the first portion than when the interaction element mechanically cooperates with the second portion.

In one embodiment, the cartridge holder is rotated a greater angle relative to the body when the interaction element mechanically cooperates with the second portion than when the interaction element mechanically cooperates with the first portion.

In one embodiment, the cartridge holder is rotated about the same angle relative to the body at a time when the interaction element mechanically cooperates with the second portion and when the interaction element mechanically cooperates with the first portion.

In one embodiment, the interaction member for separating the cartridge holder and the body is configured to mechanically cooperate with the second portion and with the first portion of the guideway such that the cartridge holder is rotated in a second direction relative to the body. The second direction may be opposite to the first direction.

The mechanical interaction of the interaction element and the second section may be mechanical interaction of the interaction element and the first Follow section to separate the cartridge holder and the body.

To separate the cartridge holder and the body, a reverse movement of the cartridge holder may be required as compared to the movement to connect. There is no need for additional separation movements. In this way, the handling of a drug delivery device can be facilitated to provide increased user comfort.

In one embodiment, the guideway includes a groove. The at least one guideway may be disposed on an outer surface of the cartridge holder. Alternatively, the guideway may be disposed on the body, for example on an interior surface of the body. The interaction element may comprise a projection or pin. The at least one interaction element may be disposed on an inner surface of the body. Alternatively, the interaction element may be disposed on the cartridge holder, for example on an outer surface of the cartridge holder.

In one embodiment, the guideway is disposed at the proximal end portion of the cartridge holder. The proximal end portion may have at least one indentation. The guideway may be arranged so that the distal end of the indentation merges into the proximal end of the first section of the guideway.

The indentation may have an angular extent that is greater than the angular extent of the first section. The indentation may have a bevelled edge designed to facilitate insertion of the interaction element into the indentation. By providing the indentation in the proximal end portion, the interaction element can be easily guided into the first portion of the guideway as it is inserted into the indentation.

In one embodiment, the first portion and the second portion of the guideway merge into one another.

In this way, a continuous rotational movement of the cartridge holder can be made possible, in particular a rotation of the cartridge holder without abrupt movements or interruptions when the cartridge holder is connected to the device.

In one embodiment, the cartridge holder may comprise two different guideways. The guideways may be arranged opposite each other. The body may comprise two interaction elements. The interaction elements may be arranged opposite each other.

By providing two guideways and two interaction elements, secure and easily manageable connection of the cartridge holder to the body can be made possible.

Another aspect relates to a cartridge holder for a drug delivery device. The cartridge holder may comprise the above-described cartridge holder. The cartridge holder may comprise at least one guideway. The guideway may include a first section. The first section may extend obliquely relative to the longitudinal axis of the cartridge holder. The guideway may include a second section. The second portion may be less obliquely related to the longitudinal axis of the cartridge holder than the first portion. The second section may be transverse to the longitudinal axis of the cartridge holder.

The path defined by the first section may include an angle with the longitudinal axis of the cartridge holder. The angle enclosed by the path defined by the first section with the longitudinal axis may be less than the angle enclosed by the path defined by the second section with the longitudinal axis.

The track may allow for continuous rotational movement of the cartridge holder, in particular rotation without abrupt movements or interruptions when the cartridge holder is connected to the device. The rotational movement can already be performed when the cartridge holder is moved toward the device. Such a rotational movement is known from ordinary screw connections and is therefore well familiar to the user. Accordingly, the movement to connect the cartridge holder may help the user to trust the secure connection of the cartridge holder to the device. In this way, the handling of a device is facilitated to provide increased user comfort.

Of course, elements described above in connection with various aspects and embodiments may be combined with each other and with features described below.

Other elements and refinements will become apparent from the following description of the Example embodiments in conjunction with the accompanying drawings will become apparent.

1 shows a schematic side sectional view of a drug delivery device,

2A and 2 B show a schematic perspective side view of the drug delivery device of 1 .

3 shows a schematic perspective side view of a body,

the 4A and 4B show a schematic perspective side view of a cartridge holder.

Identical elements, elements of the same type and identically acting elements can be provided with the same reference numbers in the figures.

The 1 . 2A and 2 B show a drug delivery device 1 , The drug delivery device 1 includes a body 3 , The drug delivery device 1 and the body 3 have a distal end and a proximal end. The distal end is through the arrow 8th characterized. The proximal end is through the arrow 9 characterized. The term "distal end" refers to the end of the drug delivery device 1 or a component thereof closest to the dispensing end of the drug delivery device 1 is to be located or arranged. The term "proximal end" refers to the end of the device 1 or a component thereof farthest from the dispensing end of the device 1 is to be located or arranged. The distal end and the proximal end are spaced apart in the direction of an axis. The axis can be the longitudinal axis 14 the device 1 be (see 1 ).

The drug delivery device 1 includes a cartridge holder 2 , The cartridge holder 2 includes coupling agents 5 a thread, for example, for releasably connecting a needle assembly (not expressly shown) to the cartridge holder 2 , A cap 21 (please refer 2A and 2 B ) can protect the device 1 and in particular the cartridge holder 2 environmental influences on the drug delivery device 1 be attached.

The drug delivery device 1 includes a cartouche 6 , The cartouche 6 is in the cartridge holder 2 recorded. The cartridge holder 2 stabilizes the position of the cartridge 6 mechanically. The cartouche 6 contains a medicine 11 , preferably a plurality of doses of the drug 11 ,

The Medicine 11 may be a fluid drug. The term "drug" as used herein means a pharmaceutical formulation containing at least one pharmaceutical agent,
wherein the pharmaceutical agent in one embodiment has a molecular weight of up to 1500 Da and / or a peptide, a protein, a polysaccharide, a vaccine, a DNA, an RNA, an enzyme, an antibody or a fragment thereof, a hormone or a Oligonucleotide or a mixture of said pharmaceutical agents,
wherein in another embodiment, the pharmaceutical agent for the treatment and / or prevention of diabetes mellitus or diabetes mellitus associated complications such. As diabetic retinopathy, thromboembolic disorders such. Deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis,
wherein in another embodiment, the pharmaceutical agent comprises at least one peptide for the treatment and / or prevention of diabetes mellitus or diabetes mellitus associated complications such. Diabetic retinopathy,
in another embodiment, the pharmaceutically active ingredient is at least one human insulin or human insulin analog or derivative, glucagon-like peptide (GLP-1) or an analog or derivative thereof or exedin-3 or exedin-4 or an analog or derivative of exedin -3 or exedin-4.

Insulin analogs include Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp (B28) human insulin; Human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which at position B29 Lys may be replaced by Pro; Ala (B26) human insulin; Des (B28-B30) human insulin; Des (B27) human insulin and Des (B30) human insulin.

Insulin derivatives are, for example, B29-N-myristoyl des (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29-human insulin; B28-N-palmitoyl-LysB28ProB29-human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N- (N-palmitoyl-Y-glutamyl) -des (B30) human insulin; B29-N- (N-lithocholyl-Y-glutamyl) -des (B30) human insulin; B29-N- (ω-carboxyheptadecanoyl) -des (B30) -human insulin and B29-N- (ω-carboxyheptadecanoyl) -human insulin.

Exendin-4 means, for example, exendin-4 (1-39), a peptide with the Sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

For example, exendin-4 derivatives are selected from the following list of compounds:

H- (Lys) 4-desPro36, desPro37-Exendin-4 (1-39) -NH 2,
H- (Lys) 5-desPro36, desPro37-Exendin-4 (1-39) -NH 2,
desPro36 [Asp28] -Exendin-4 (1-39),
desPro36 [IsoAsp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Asp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, IsoAsp28] -Exendin-4 (1-39),
desPro36 [Trp (O2) 25, Asp28] -Exendin-4 (1-39),
desPro36 [Trp (O2) 25, IsoAsp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, IsoAsp28] -Exendin-4 (1-39); or

desPro36 [Asp28] -Exendin-4 (1-39),
desPro36 [IsoAsp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Asp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, IsoAsp28] -Exendin-4 (1-39),
desPro36 [Trp (O2) 25, Asp28] -Exendin-4 (1-39),
desPro36 [Trp (O2) 25, IsoAsp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, IsoAsp28] -Exendin-4 (1-39),
wherein the group -Lys6-NH2 may be bound to the C-terminus of the exendin-4 derivative;

or an exendin-4 derivative having the sequence
H- (Lys) 6-desPro36 [Asp28] -Exendin-4 (1-39) -Lys6-NH2,
desAsp28, Pro36, Pro37, Pro38 exendin-4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro38 [Asp28] -Exendin-4 (1-39) -NH 2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Asp28] -Exendin-4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) -Lys6-NH2,
H-desAsp28, Pro36, Pro37, Pro38 [Trp (O2) 25] -Exendin-4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) -NH 2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36 [Met (O) 14, Asp28] -Exendin-4 (1-39) -Lys6-NH2,
DeSmet (O) 14, Asp28, Pro36, Pro37, Pro38 exendin-4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) -NH 2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H-Lys 6-desPro36 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39) -Lys6-NH2,
H-desAsp28, Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] -Exendin-4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] -Exendin-4 (1-39) -NH 2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (S1-39) - (Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] -Exendin-4 (1-39) - (Lys) 6-NH2;

or a pharmaceutically acceptable salt or solvate of one of the aforementioned exendin-4 derivatives.

Hormones are, for example, pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists as listed in the Red List, edition 2008, chapter 50 , such as Gonadotropin (follitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

A polysaccharide is, for example, a glucosaminoglycan, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof or a sulfated, e.g. a polysulfated, form of the above polysaccharides and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a low molecular weight polysulphated heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (~ 150 kDa), also known as immunoglobulins are and have a basic structure in common. Because they have sugar chains attached to amino acid residues, they are glycoproteins. The functional moiety of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig moiety); secreted antibodies may also be dimeric with two Ig units, as in IgA, tetramer with four Ig units, such as bone fish IgM, or pentamer with five Ig units, such as mammalian IgM.

The Ig monomer is a "Y" shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains linked by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain disulfide bonds within the chains that stabilize their folding. Each chain consists of structural domains called Ig domains. These domains contain about 70-110 amino acids and are categorized according to their size and function (for example variable or V and constant or C). They have a characteristic immunoglobulin fold in which two β-sheets form a "sandwich" shape, which is held together by interactions between conserved cysteines and other charged amino acids.

There are five types of heavy chains of mammalian Ig, designated α, δ, ε, γ and μ. The type of heavy chain present defines the isotype of the antibody; these chains are found in IgA, IgD, IgE, IgG or IgM antibodies.

Individual heavy chains vary in size and composition; α and γ contain about 450 amino acids and δ about 500 amino acids, while μ and ε have about 550 amino acids. Each heavy chain has two areas, the constant area (C _H ) and the variable area (V _H ). In one species, the constant region is essentially identical for all antibodies of the same isotype, but differs between antibodies of different isotypes. Heavy chains γ, α and δ have a constant region consisting of three tandem Ig domains and a hinge region for added flexibility; the heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable range of heavy chains differs between antibodies produced by different B cells, but is the same in all antibodies produced by a single B cell or a B cell clone. The variable region of each heavy chain is about 110 amino acids long and consists of a single Ig domain.

In mammals, there are two types of immunoglobulin light chain, designated λ and κ. A light chain has two consecutive domains: a constant domain (CL) and a variable domain (VL). The length of a light chain is about 211 to 217 amino acids. Each antibody contains two light chains that are always identical; in mammals, only one type of light chain, κ or λ, per antibody is present.

Although the general structure of all antibodies is very similar, the individual properties of a given antibody are determined by the variable (V) regions described above. In particular, variable loops, three each at the light chain (VL) and three at the heavy chain (VH), are for binding to the antigen, i. H. responsible for its antigenic specificity. These loops are referred to as Complementarity Determining Regions (CDRs). Since CDRs contribute to the antigen-binding site from both VH and VL domains, it is the combination of heavy and light chains, not one of them alone, that determines the ultimate antigenic specificity.

An "antibody fragment" contains at least one antigen-binding fragment as defined above and exhibits substantially the same function and specificity as the complete antibody from which the fragment is derived. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing an entire L chain and about half of an H chain, are the antigen-binding fragments (Fab). The third fragment, which has a similar size but contains the carboxy-terminal half of both heavy chains with their interchain disulfide bond, is the crystallizable fragment (Fc). The Fc contains carbohydrates, complement binding and FcR binding sites. Limited pepsin digestion yields a single F (ab ') 2 fragment containing both Fab fragments and the hinge region, including the H-H interchain disulfide bond. F (ab ') 2 is divalent for antigen binding. The disulfide bond of F (ab ') 2 can be cleaved to obtain Fab'. Further, the heavy and light chain variable regions may be fused together to obtain a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. Acid addition salts are, for example, HCl and HBr salts. Base salts are, for example, salts with a cation selected from alkali or alkaline earth, for example Na + or K + or Ca 2+, or an ammonium ion N + (R 1) (R 2) (R 3) (R 4), where R 1 to R 4 independently of one another mean: Hydrogen, an optionally substituted C1-C6 alkyl group, an optionally substituted C2-C6 alkenyl group, an optionally substituted C6-C10 aryl group or an optionally substituted C6-C10 heteroaryl group. Further examples of pharmaceutically acceptable salts are disclosed in U.S. Pat "Remington's Pharmaceutical Sciences", 17th ed., Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985, and the Encyclopedia of Pharmaceutical Technology described.

Pharmaceutically acceptable solvates are for example hydrates.

The drug delivery device 1 may be a pen-type device, in particular a pen-type injector. The device 1 can be used to spend steady doses of the drug 11 be designed, ie of doses that can not be changed by a user, or of user-adjustable doses of the drug 11 , A stopper 7 is movable in the cartridge 6 arranged. The stopper 7 seals the cartridge 6 proximal. Movement of the plug 7 distally relative to the cartridge 6 causes the drug 11 from the cartouche 6 is issued.

The body 3 contains a drive mechanism 4 . 10 . 19 the device 1 , The drive mechanism 4 . 10 . 19 drives a piston rod 17 in the distal direction relative to the body 3 to get a dose of the drug 11 issue. The drive mechanism 4 . 10 . 19 prevents the proximal movement of the piston rod 17 related to the body 3 during a dose setting process. At the distal end of the piston rod 17 is a storage element 15 arranged and abuts the proximal side of the plug 7 at.

3 shows a schematic perspective side view of a body 3 ,

The cartridge holder 2 is removable with the body 3 the drug delivery device 1 connected. The body 3 includes two interaction elements 13 , where in 3 only one of the interaction elements 13 will be shown. Alternatively, the body can 3 only one interaction element 13 include, or even multiple, for example, three or four interaction elements 13 ,

The interaction elements 13 are at the distal end portion of the body 3 arranged, ie the end portion, with the cartridge holder 2 to be connected. The interaction elements 13 are on the inner surface of the body 3 arranged. The two interaction elements 13 are arranged opposite each other.

The interaction element 13 includes a pin. The pin protrudes from the inner surface of the body 3 radially inward. At the in 3 embodiment shown is the angular extent of the interaction element 13 greater than its axial extent. The situation can also be reversed, ie the axial extent of the interaction element 13 can be greater than its angular extent. Alternatively, the interaction element 13 have a square or circular shape. The corresponding interaction element 13 acts with a corresponding guideway 12 of the cartridge holder 2 mechanically together.

The 4A and 4B show a schematic perspective side view of the cartridge holder 2 ,

The cartridge holder 2 includes two guideways 12 , Alternatively, the cartridge holder 2 only one guideway 12 include, but also several, for example, three or four guideways 12 , The number of guideways 12 corresponds to the number of interaction elements 13 , The guideways 12 are at the proximal end portion of the cartridge holder 2 arranged, ie the end portion, with the body 3 to be connected. The guideways 12 are on the outer surface of the cartridge holder 12 arranged. The guideways 12 are grooves. The two guideways 12 are arranged opposite each other.

The corresponding guideway 12 (please refer 4B ) includes a first section 12A , The guideway 12 includes a second section 12B , The first paragraph 12A runs obliquely relative to the longitudinal axis 14 (please refer 1 ) of the device 1 , In particular, that concludes through the first section 12A defined way an angle with the longitudinal axis 14 the device 1 one. The angle of that through the first section 12A defined path with the longitudinal axis 14 is included in the in the 4A and 4B shown embodiment about 45 degrees. However, other angles are conceivable, for example, the angle may be a minimum value of 10 degrees or a maximum value of 120 degrees. The second section 12B runs less obliquely relative to the longitudinal axis 14 as the first section 12A , The angle of that through the first section 12A defined path with the longitudinal axis 14 is smaller than the angle, that of the second section 12B defined path with the longitudinal axis 14 is included. The angle of that through the second section 12B defined path with the longitudinal axis 14 is included in the in the 4A and 4B shown embodiment 90 degrees.

The first paragraph 12A and the second section 12B form a continuous guideway 12 , In other words, for connecting or disconnecting the cartridge holder 2 and the body 3 the interaction element 13 from the first section 12A directly into the second section 12B kick and vice versa.

The second section 12B includes an angular stop surface 20 , The angular stop surface 20 is from a sidewall of the second section 12B educated. When the interaction element 13 with the angular stop surface 20 mechanically cooperates, the further rotation of the cartridge holder 2 related to the body 3 for connecting the cartridge holder 2 and the body 3 prevented.

The cartridge holder 2 also includes two indentations 16 , The indentations 16 are at the proximal end portion of the cartridge holder 2 arranged. The two indentations 16 are arranged opposite each other. The corresponding indentation 16 has beveled edges. The indentation 16 has an angular extent greater than the angular extent of the first section 12A is. Alternatively, the indentation 16 have an angular extent that is smaller than the angular extent of the first section 12A is. The distal end of the corresponding indentation 16 goes into the proximal end of the first section 12A the corresponding guideway 12 above.

To connect the cartridge holder 2 with the body 3 becomes the cartridge holder 2 related to the body 3 moved, in particular moved axially and / or rotated. The cartridge holder 2 is related to the body 3 moves until the interaction element 13 with the indentation 16 interacts mechanically. Upon further movement of the cartridge holder 2 related to the body 3 the interaction element is in mechanical cooperation with the first section 12A brought. When the interaction element 13 with the first section 12A interacts mechanically, becomes the cartridge holder 2 proximal to the body 3 moved, leaving the first section 12A along the interaction element 13 slides. This will cause the cartridge holder 2 in a first direction relative to the body 2 turned. In this embodiment, the cartridge holder 2 rotated about an angle of about 30 degrees relative to the body, while the interaction element 13 with the first section 12A interacts mechanically. The angle is defined by the angle as described above, that by the first section 12A defined path with the longitudinal axis 14 includes.

At the distal end of the first section 12A goes the first section 12A directly into the second section 12B above. At the distal end of the first section 12A becomes the interaction element 13 in mechanical cooperation with a distal and a proximal wall 22 . 23 (please refer 4B ) of the second section 12B brought, so that further axial movement of the cartridge holder 2 related to the body 3 is prevented. In particular, prevents the mechanical interaction of the interaction element 13 with the distal wall 23 further proximal movement of the cartridge holder 2 related to the body 3 during the process of joining.

Accordingly, the cartridge holder becomes 2 turned further in the first direction, but no longer axially related to the body 3 emotional. The cartridge holder 2 is turned so that the second section 12B along the interaction element 13 slides until the interaction element 13 with the angular end stop element 20 interacts mechanically. The cartridge holder 2 is turned in the same direction when the interaction element 13 with the first and the second section 12A . 12B Mechanically interacts with the cartridge holder 2 with the body 3 connect to.

When the interaction element 13 with the angular end stop element 20 interacts mechanically, is another rotation of the cartridge holder 2 prevented in the first direction. When the interaction element 13 with the angular end stop element 20 interacts mechanically, is the cartridge holder 2 firmly with the body 3 connected. The mechanical interaction of the interaction element 13 with the angular end stop element 20 may provide a tactile feedback indicating to the user that the cartridge holder 2 firmly with the body 3 connected is.

To disconnect the cartridge holder 2 and the body 3 becomes the cartridge holder 2 turned in a second direction. The second direction is opposite to the first direction. This slides the second section 12B along the interaction element 13 of the body 3 , wherein axial movement of the cartridge holder 2 related to the body 3 by mechanical interaction of the interaction element 13 with the distal and the proximal wall 22 . 23 of the second section 12B is prevented.

Upon further rotation of the cartridge holder 2 in the second direction slides the first section 12A along the interaction element 13 , If the first section 12A along the interaction element 13 slides, the cartridge holder 2 distally related to the body 3 moved to the cartridge holder 2 and the body 3 to separate.

The interaction element 13 and the first section 12A and the second section 12B have dimensions in which the interaction element 13 at any time during the operations of joining and separating with the walls of the sections 12A and 12B interacts mechanically. In particular, the interaction element abuts 13 to the side walls of the first section 12A when the interaction element 13 interacts mechanically with the first section. When the interaction element 13 interacts mechanically with the second section, it abuts the distal and proximal walls 22 . 23 of the second section 12B at. As the first and the second section 12A . 12B merge into each other, ie the side walls of the first section 12A into the distal and proximal walls 22 . 23 of the second section 12B go over, is the interaction element 13 at any time during the operations of connecting and disconnecting in mechanical contact with the wall of one of the sections 12A . 12B ,

LIST OF REFERENCE NUMBERS

1

Drug delivery device

2

cartridge holder

3

body

4

drive mechanism

5

coupling agent

6

cartridge

7

Plug

8th

distal end

9

proximal end

10

drive mechanism

11

drug

12

guideway

12A

first section

12B

second part

13

Interaction element

14

longitudinal axis

15

storage element

16

indentation

17

piston rod

19

drive mechanism

20

angular end stop element

21

cap

22

proximal wall

23

distal wall

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 1923083 A1 [0003]

Cited non-patent literature

• Red List, Edition 2008, chapter 50 [0049]
• "Remington's Pharmaceutical Sciences", 17th Ed., Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985, and the Encyclopedia of Pharmaceutical Technology [0058]

Claims (12)

Drug delivery device ( 1 ) - a cartridge holder ( 2 ) comprising at least one guideway ( 12 ), - a body ( 3 ) comprising at least one interaction element ( 13 ), designed and arranged for mechanical interaction with the at least one guideway ( 12 ), whereby the guideway ( 12 ) a first section ( 12A ) and a second section ( 12B ), the path defined by the first section ( 12A ) is defined with the longitudinal axis ( 14 ) of the device ( 1 ) includes an angle, the angle subtended by that through the first section ( 12A ) defined path with the longitudinal axis ( 14 ) is less than the angle subtended by the second section ( 12B ) defined path with the longitudinal axis ( 14 ), wherein for connecting the cartridge holder ( 2 ) with the body ( 3 ) the interaction element ( 13 ) with the first section ( 12A ) cooperate mechanically so that the cartridge holder ( 2 ) relative to the body ( 3 ) is axially moved and rotated, and the interaction element ( 13 ), with the second section ( 12B ) cooperate mechanically so that the cartridge holder ( 2 ) relative to the body ( 3 ) is rotated, whereby an axial movement of the cartridge holder ( 2 ) relative to the body ( 3 ), characterized in that the guideway ( 12 ) at the proximal end portion of the cartridge holder ( 2 ), wherein the proximal end portion has at least one indentation ( 16 ), wherein the guideway ( 12 ) is arranged so that the distal end of the indentation ( 16 ) in the proximal end of the first section ( 12A ) of the guideway ( 12 ) passes over. Drug delivery device ( 1 ) according to claim 1, wherein the cartridge holder ( 2 ) during the mechanical interaction of the interaction element ( 13 ) with the first and second sections ( 12A . 12B ) in a first direction relative to the body ( 3 ) is rotated. Drug delivery device ( 1 ) according to claim 2, wherein the second section ( 12B ) an angular end stop element ( 20 ), designed and arranged to prevent further relative rotation of the cartridge holder (US Pat. 2 ) and the body ( 3 ) in the first direction by mechanical interaction of the angular end stop element (FIG. 20 ) with the interaction element ( 13 ). Drug delivery device ( 1 ) according to any one of the preceding claims, wherein the cartridge holder ( 2 ) relative to the body ( 3 ) is rotated by less than one revolution when the interaction element ( 13 ) with the first section ( 12A ) cooperates mechanically, and wherein the cartridge holder ( 2 ) relative to the body ( 3 ) is rotated by less than one revolution when the interaction element ( 13 ) with the second section ( 12B ) interacts mechanically. Drug delivery device ( 1 ) according to any one of the preceding claims, wherein the cartridge holder ( 2 ) at a greater angle relative to the body ( 3 ) is rotated when the interaction element ( 13 ) with the first section ( 12A ) interacts mechanically as if the interaction element ( 13 ) with the second section ( 12B ) interacts mechanically. Drug delivery device ( 1 ) according to one of claims 2 to 5, wherein for separating the cartridge holder ( 2 ) and the body ( 3 ) the interaction element ( 13 ), with the second section ( 12B ) and the first section ( 12A ) of the guideway ( 12 ) cooperate mechanically so that the cartridge holder ( 2 ) in a second direction relative to the body ( 3 ) is rotated, wherein the second direction is opposite to the first direction. Drug delivery device ( 1 ) according to any one of the preceding claims, wherein the first section ( 12A ) and the second section ( 12B ) of the guideway ( 12 ) merge. Drug delivery device ( 1 ) according to one of the preceding claims, wherein the at least one guideway ( 12 ) on an outer surface of the cartridge holder ( 2 ) is arranged. Drug delivery device ( 1 ) according to one of the preceding claims, wherein the at least one interaction element ( 13 ) on an inner surface of the body ( 3 ) is arranged. Drug delivery device ( 1 ) according to one of the preceding claims, wherein the at least one interaction element ( 13 ) comprises a projection. Drug delivery device ( 1 ) according to one of the preceding claims, wherein the at least one guideway ( 12 ) comprises a groove. Drug delivery device ( 1 ) according to any one of the preceding claims, wherein the cartridge holder ( 2 ) two different guideways ( 12 ), wherein the guideways ( 12 ) are arranged opposite one another, and wherein the body ( 3 ) two different interaction elements ( 13 ), wherein the Interaction elements ( 13 ) are arranged opposite one another.

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